FDA import alert status
MANDELAY KFT
Hungary · appears on 3 FDA import alerts
3
Red-list alerts
0
Green-list alerts
Hungary
Country
09/16/2009
Last entry seen
What this means
As published on the official FDA import alert list, this firm appears on 3 red lists. A red-list firm is subject to Detention Without Physical Examination (DWPE): FDA can detain its shipments at the border automatically, without sampling. The burden shifts to the importer to prove the goods are not violative.
Import alert status changes over time. Import Alert Radar re-checks the official FDA source every day; the entries below reflect the latest refresh (2026-07-21 UTC).
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Red-list entries
- Import Alert 80-06RED · 09/16/2009
Detention Without Physical Examination of Medical Devices with False or Misleading Labeling
- Import Alert 89-04RED · 03/09/2020
Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements
- Import Alert 89-08RED · 01/23/2019
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
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